Salsabeel M Abdelgaffar
Tanta, ELGharbia, 31527, Egypt
Location contact
Ahmed I El Dosoky, Assistant Professor
SUB_INVESTIGATOR
Fatma A El-Hendawy, Professor
SUB_INVESTIGATOR
Salsabeel M Abdelgaffar, B.D.S
CONTACT
NCT Number: NCT06729788
The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.
Trial opening soon.
Get Notified6 year–8 year
All sexes
Interventional
Phase 4
Tanta, ELGharbia, 31527, Egypt
Ahmed I El Dosoky, Assistant Professor
SUB_INVESTIGATOR
Fatma A El-Hendawy, Professor
SUB_INVESTIGATOR
Salsabeel M Abdelgaffar, B.D.S
CONTACT
Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro
Time frame: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months
172 permanent mandibular molars out of 86 children will be randomly allocated into two equal groups. Group 1: The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK). Group 2: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).For application of ICON, an ample amount of Icon-Infiltrate is applied into the fissure away from the direct light of the dental unit and let sit for 3 minutes. After excess removal, it will be cured with a light source. A second layer of the Icon Infiltrate was applied and cured in the same way. For Heliosael application, The sealant will be carefully applied starting from the maximum depth of the central fissure up towards two. Sealant retention will be evaluated using Simonsen's criteria. (Completely present: no sealant ledge is present, Partially present: part of the sealed pit or fissure, Complete missing: no sealant ledge is present.
Time frame: thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months
20 teeth will be randomly assigned into two equal experimental groups . Experimental Group I: The fissure of selected teeth will be sealed with ICON resin infiltration. Experimental Group II: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).
After removal from the dye teeth will be rinsed with water, cleaned, and sectioned longitudinally through the center of the restorations in a buccolingual direction with a double-sided diamond disc and will be given a code number to permit blind evaluation. For each specimen, the dye penetration along the buccal and lingual margins on each sectioned surface will be digitally photographed at 10x under a stereomicroscope. The degree of microleakage was scored by a single observer.
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Evaluation of Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars (In Vivo& In Vitro)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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